clonidine hydrochloride
- Product NDC
- 70518-1035
- 11-digit product format
- 705181035
- Labeler code
- 70518
- Product ID
- 70518-1035_5100773e-8dcc-aced-e063-6294a90a3c83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clonidine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA091368
- Marketing category
- ANDA
- Marketing start
- 2018-02-27
- Substance
- CLONIDINE HYDROCHLORIDE
- Active strength
- .1 mg/1
- Pharmacologic classes
- Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70518-1035 | 70518-1035-0 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-1035 | 70518-1035-1 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-1035 | 70518-1035-2 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-1035 | 70518-1035-3 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 70518-1035 | 70518-1035-4 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-1035-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-1035-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-1035-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-1035-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-1035-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-1035-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-1035-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-1035-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-1035-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-1035-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-1035-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-1035-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-1035-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-1035-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-1035-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-1035-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-1035-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-1035-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-1035-0 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-1035-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-1035-2 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-1035-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-1035-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-1035-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-1035-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-1035-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-1035-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-1035-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-1035-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-1035-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-1035-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-1035-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-1035-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-1035-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-1035-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-1035-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091368-001 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | |
| A091368-002 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | |
| A091368-003 | CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091368-001 | AB |
| A091368-002 | AB |
| A091368-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091368-002 | CLONIDINE HYDROCHLORIDE | 0.2MG | TABLET / ORAL | AB | 2011-12-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091368-003 | CLONIDINE HYDROCHLORIDE | 0.3MG | TABLET / ORAL | AB | 2011-12-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091368-001 | CLONIDINE HYDROCHLORIDE | 0.1MG | TABLET / ORAL | AB | 2011-12-06 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091368-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091368-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091368-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091368-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091368-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091368-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091368-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091368-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091368-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091368-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091368-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091368-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091368-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091368-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091368-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091368-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091368-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091368-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091368-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091368-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- clonidine hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLONIDINE HYDROCHLORIDE | .1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| W76I6XXF06 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 884173 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 574640a5-829d-4e9d-be32-832a48cbd8dd | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 45c8ba14-e378-46f0-b21f-1aad8e08c613 | Product name | 1 | 20250221 |
| 6920b0ed-30bc-b127-73e1-0713049bd41e | Product name | 9 | 20190618 |
| 6920b0ed-30bc-b127-73e1-0713049bd41e | Product name | 5 | 20171212 |
| 48f5a4fd-7cdc-dc04-771d-ce7a47326789 | Product name | 2 | 20150123 |
| 624cf764-e200-44b5-83c2-84526255adb5 | Product name | 1 | 20150107 |
| 47972e1b-c905-eeee-5e77-eb4538ad833c | Product name | 1 | 20140508 |
| 7667d8e2-e5be-36e1-4de7-231aa7fdaf5c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-1035-0 | clonidine hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 14 | |
| 70518-1035-1 | clonidine hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | 14 | |
| 70518-1035-2 | clonidine hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 14 | |
| 70518-1035-3 | clonidine hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 14 | |
| 70518-1035-4 | clonidine hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 14 | |
| 70518-1035-5 | clonidine hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 14 | |
| 70518-1035-6 | clonidine hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET | 180 | 14 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-1035 | CLONIDINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 9 | Current NDC, Legacy NDC, 7 package rows | 20250504_574640a5-829d-4e9d-be32-832a48cbd8dd.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | REMEDYREPACK INC. | 574640a5-829d-4e9d-be32-832a48cbd8dd | 2026-07-02 | Warnings, Adverse reactions | 091368 ANDA091368 70518-1035 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | REMEDYREPACK INC. | 2a183d05-5be7-43e9-a084-700ec05d01e9 | 2026-07-02 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Redpharm Drug | 53df40e7-dd2b-d40e-e063-6394a90a21c4 | 2026-06-10 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 666e757e-9b43-2e40-e053-2991aa0a59a2 | 2026-05-05 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 3939ecd7-08f9-4eb2-b4d8-bb7ebc2004d6 | 2026-03-31 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 56a80e79-9cfe-4361-a90a-9245632efa05 | 2026-03-31 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 770b56aa-fcf3-4327-98d1-d87e5a037234 | 2026-03-31 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | VERITYRX, LLC | 42788adf-a54d-3545-e063-6394a90a8c69 | 2025-10-31 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 746dcdfd-7dfb-4a29-e053-2991aa0a8a4c | 2025-05-07 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | 100a31f2-9a8e-4245-a09c-05583c3244c3 | 2025-03-31 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | 1c13555e-acfc-4a3a-93cd-e6f012f36c61 | 2025-03-28 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5366a055-47fd-41eb-81d8-ffb3be1dc38c | 2025-02-05 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | 61b56917-1442-4068-86d8-0e5a5a59e612 | 2025-01-23 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | A-S Medication Solutions | 329382fb-ccf8-488d-a0b2-68ff959a0846 | 2024-12-20 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | A-S Medication Solutions | aecd05bf-e7ba-4cab-9494-4ce3bbd1aa99 | 2024-12-20 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Bryant Ranch Prepack | be6c29cd-1692-4dd3-868e-7efcb3a85056 | 2024-08-23 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a9de8b29-5cd2-a49d-e053-2995a90a4f0e | 2024-07-17 | Warnings, Adverse reactions | 091368 ANDA091368 |
| CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | DirectRX | 2823a922-3217-6062-e054-00144ff88e88 | 2024-01-09 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 88a8db46-0fc9-48cd-b7cc-ac9c9cdea100 | 2023-01-27 | Warnings, Adverse reactions | 091368 ANDA091368 |
| clonidine hydrochloride | CLONIDINE HYDROCHLORIDE | Asclemed USA, Inc. | b60034a6-b8ba-4e54-9ef0-029965e67bc0 | 2020-10-24 | Warnings, Adverse reactions | 091368 ANDA091368 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 884173 | cloNIDine HCl 0.1 MG Oral Tablet | PSN | 574640a5-829d-4e9d-be32-832a48cbd8dd | 14 |
| 884173 | clonidine hydrochloride 0.1 MG Oral Tablet | SCD | 574640a5-829d-4e9d-be32-832a48cbd8dd | 14 |
| 884173 | clonidine HCl 100 MCG Oral Tablet | SY | 574640a5-829d-4e9d-be32-832a48cbd8dd | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-1035-0 | 70518103500 | 30 in 1 BLISTER PACK | Historical | ||||
| 70518-1035-1 | 70518103501 | 180 in 1 BOTTLE, PLASTIC | Historical | ||||
| 70518-1035-2 | 70518103502 | 90 in 1 BOTTLE, PLASTIC | Historical | ||||
| 70518-1035-3 | 70518103503 | 30 in 1 BLISTER PACK | Historical | ||||
| 70518-1035-4 | 70518103504 | 30 in 1 BOTTLE, PLASTIC | Historical | ||||
| 70518-1035-5 | 70518103505 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1035-5) | 90 tablet | 2025-07-01 | No | No | Current |
| 70518-1035-6 | 70518103506 | 180 TABLET in 1 BOTTLE, PLASTIC (70518-1035-6) | 180 tablet | 2025-07-01 | No | No | Current |